NCT06635954 A Prospective Real World Evidence Study (PROWES) for Concordance Rate of Blood-based 3D Genome Conformation Mapping (Episwitch CiRT®) to Identify Likelihood of Response and Actual Response Rates to PD-(L)-1 Checkpoint Inhibitors Across Multiple Oncological Indications.
| NCT ID | NCT06635954 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oxford Biodynamics Inc. |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2024-05-14 |
| Primary Completion | 2026-05-14 |
Trial Parameters
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Brief Summary
The purpose of this research is to test whether a blood-based 3D genome conformation mapping test called the Episwitch CiRT® can help to identify likelihood of response to PD-(L)-1 checkpoint inhibitors (a class of cancer drugs) across multiple oncological indications by comparing the results to actual treatment responses for cancer patients.
Eligibility Criteria
Inclusion Criteria: 1. 18 years of age or older 2. Stage III or IV cancer 3. Selected by their healthcare provider to receive the Episwitch CiRT® test according to the current evidence-based schedule (per protocol) as part of their standard of practice. 4. ECOG performance status ≤ 2 5. Clinically eligible for ICI therapy 6. Able to read, understand and provide written informed consent. 7. Willing and able to comply with the study requirements Exclusion Criteria: 1. Pregnant or breastfeeding 2. History of bone marrow or organ transplant 3. Contra indication for receiving Immune Check Point inhibitor.
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